The Comparison Effect Of Curcumin Nanomicelle With Metformin In Treatment Of Women With Polycystic Ovary Syndrome
Design
Patients Were Randomly Divided Into Two Groups of 50 Each. The First Group Was Treated With Metformin Tablets (500 Mg, Three Times Daily) And The Second Group Treated With Metformin Tablets (500 Mg, Three Times Daily) And The Nanomicelle Curcumin (80 Mg) Once Daily For 12 Weeks
Settings and conduct
The Study Is A Single-Blind Clinical Trial Conducted At Shahid Sadoughi Hospital, And One Of The Treatment Centers Of Shahid Sadoughi University Of Medical Sciences, Lasting Three Months. .Randomization Was Also Performed By Random Sequence Generation Software
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age, Observation Of Ovaries And Menstrual Cycle
Exclusion Criteria: Use Of Certain Drugs And Specific Diseases In The Last 90 Days And A Number Of Emerging Clinical Conditions That Make Continuing Treatment Impossible And Immoral
Intervention groups
Determination And Comparison Of Laboratory Data And Complications Of Metformin And Curcumin Groups Before And After Treatment
Comparison The Therapeutic Effect of Curcumin Nanomicelle And Metformin In Women With Polycystic Ovarian Syndrome
Public title
Comparison The Therapeutic Effect Of Curcumin Nanomicelle And Metformin In Women With Polycystic Ovarian Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 40
Observe 12 Follicles Or More In Size Of 2-9 Mm In The Ovary By Ultrasound
Oligomenorrhea or Amenorrhea In The Last 6 Months
Testosterone Levels Above 0.7 ng/dl
Serum Insulin Levels Above 16 U/ml
Exclusion criteria:
Pregnancy And Lactation During The Last 90 Days And Discontinuation Of Medication During Treatment
Liver And Kidney Failure During The Last 90 Days And Discontinuation Of Medication During Treatment
Thyroid Dysfunction During The Last 90 Days And Discontinuation Of Medication During Treatment
Hyper Prolactinemia During The last 90 Days And Discontinuation Of Medication During Treatment
Adrenal Dysfunction During The Last 90 Days And Discontinuation Of Medication During Treatment
Congenital Adrenal Hyper Plasia During The Last 90 Days And Discontinuation Of Medication During Treatment
Cushing's Syndrome During The Last 90 Days And Discontinuation Of Medication During Treatment
Use Of Contraceptives During The Last 90 Days And Discontinuation Of Medication During Treatment
Taking Estrogen And Progesterone In The Last 90 Days And Discontinuing Medication During Treatment
Ovulation Induce Medication For The Last 90 Days And Discontinue Medication During Treatment
Use Of Anti-Androgen Drugs During The Last 90 Days And Discontinuation Of Medication During Treatment
Insulin Use During The Last 90 Days And Discontinuation Of Medication During Treatment
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
50
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation Software Was Used For Block Randomization And RANUNI And RANNOR Functions Were Used To Generate Random Numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients And Statistics Experts Are Kept Blind In This Study. It Should Be Noted That All Patients Received Current And Accepted Treatment For Their Disease, And No Patients Was Excluded From Conventional Treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-11-29, 1396/09/08
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.195
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic Ovarian Syndrome
Primary outcomes
1
Description
Serum Insulin Level
Timepoint
Before Intervention And After Intervention( After Three Month)
Method of measurement
µU/ml
2
Description
Low Density Lipoprotein
Timepoint
Before Intervention And After Intervention( After Three Month)
Method of measurement
Mili Gram Per Deciliter
3
Description
High Density Lipoprotein
Timepoint
Before Lntervention And After Intervention( After Three Month)
Method of measurement
Mili Gram Per Deciliter
4
Description
Triglyceride
Timepoint
Before Intervention And After Intervention( After Three Month)
Method of measurement
Mililgram Per Deciliter
5
Description
Fast Blood Suger
Timepoint
Before Intervention And After Intervention( After Three Month)
Method of measurement
Milligram Per Deciliter
6
Description
17hydroxyprogestrone
Timepoint
Before Intervention And After Intervention( after three month)
Method of measurement
Miligram Per Liter
7
Description
Total Testosterone
Timepoint
Before Intervention And After Intervention( After Three Month)
Method of measurement
Microgram Per Liter
8
Description
LH/FSH Ratio
Timepoint
Before Intervention And After Intervention( After Three Month)
Method of measurement
IU Per Liter
9
Description
Cholesterol
Timepoint
Before Intervention And After Intervention( After Three Month)
Method of measurement
Milligram Per Deciliter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: The First Group (50 Patients) Treated With Metformin 500 Mg Three Times Daily (First Week 500 Mg Daily And Then Second Week 500 Mg Twice Daily And Third Week 500 Mg Three Times Daily And Continued With 500 Mg Three Times). Times Per Day For Three Months)
Category
Treatment - Drugs
2
Description
Intervention Group: Second Group (50 patients) Treated With Metformin 500 Mg Three Times Daily (First Week 500 Mg Daily And Then Second Week 500 Mg Twice Daily And Third Week 500 Mg Three Times Daily And Continued With 500 Mg Three Times And Nano-Micelles Of Curcumin 80 Mg Once Daily For Three Months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Seyed Mojtaba Sohrevardi
Street address
Shahid Sadoughi hospital-Riazi Square- Safayieh
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
Info@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzai
Street address
Research Department, Building No 2, Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
Education@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences
Position
Dr Seyed Mojtaba Sohrevardi/Faculty of Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
Smsohrevardi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Mojtaba Sohrevardi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
Smsohrevardi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Seyed Mojtaba Sohrevardi
Position
PhD of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
Smsohrevardi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Publishing patient information before publishing an article does not seem to be ethical